Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

Approximately five million laparotomies are performed annually in the United States with
upwards of 25% of these patients developing a ventral hernia postoperatively. Despite the
prevalence of ventral hernias, the surgical approach to these procedures lacks
standardization. In fact, nearly 20%-50% of patients undergoing ventral hernia repair (VHR)
will experience a hernia recurrence.

There are several factors that can contribute to ventral hernia recurrence. One of these is
the use of prosthetic reinforcement. Although previous studies have shown that the use of
mesh during VHR significantly decreases the risk of ventral hernia recurrence, guidelines for
the ideal prosthetic material remain unknown. In terms of synthetic mesh, there are
proponents that argue the value of medium weight material (40-60 g/m2) in order to combat the
risk of postoperative deep surgical site infection and minimize the risk of a "stiff abdomen"
or chronic pain syndromes.3-5 On the other hand, however, proponents of a heavier weight
material ( > 80 g/m2) argue that its tensile strength leads to a long-term, durable hernia
repair with decreased risk of hernia recurrence.

To help determine if mesh weight has an impact on postoperative pain, we propose a registry
based, randomized clinical trial (RCT) through the Americas Hernia Society Quality
Collaborative (AHSQC). The AHSQC is a multicenter, nationwide quality improvement effort with
a mission to improve value in hernia care.6 Data are collected prospectively in the routine
care of hernia patients for quality improvement purposes. The information collected in the
AHSQC offers a natural repository of information that can be used for research, in addition
to its quality improvement purpose. The investigators hypothesize that patients who undergo
ventral hernia repair with medium weight mesh will have significantly less pain than those
patients who undergo ventral hernia repair using heavy weight mesh one year after operation.
Both the intended randomization arms of the study are accepted standard of care practices in
use by surgeons.

Specific Aim #1: To determine if the use of a medium weight material leads to a decrease in
pain intensity at one year following ventral hernia repair.

Specific Aim #2: To determine if there is a difference in ventral hernia recurrence at one
year following surgery.

Specific Aim #3: To determine if there is a difference in the rate of deep surgical site
infection at 30-days following surgery between the two mesh types.

Specific Aim #4: To determine if there is a difference in the quality of life between the two
groups at one year following surgery.

Inclusion Criteria:

- 18 years of age or older

- Will undergo a single-stage, open, retromuscular ventral hernia repair

- CDC Wound Class 1

- Able to achieve midline fascial closure

- Hernia defect width less than or equal to 20 centimeters (measured intraoperatively)

- Able to tolerate general anesthesia

- Able to give informed consent

Exclusion Criteria:

- Patients who are less than 18 years of age

- Patients who undergo emergent ventral hernia repair

- Patients who undergo laparoscopic or robotic ventral hernia repair

- Patients with CDC Wound Class 2, 3, or 4

- Patients who are unable to undergo successful retromuscular mesh placement or who
cannot achieve midline fascial closure

- Patients who undergo staged repair of their ventral hernia

- Patients who are unable to give informed consent

- Patients who cannot tolerate general anesthesia

- Patients who are pregnant at the time of surgical intervention